Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets Recalled by Iradimed Corporation Due to Certain Iradimed 1057 Syringe Adapter Sets, used with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Iradimed Corporation directly.
Affected Products
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Quantity: 3285 boxes of 50 devices
Why Was This Recalled?
Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Iradimed Corporation
Iradimed Corporation has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report